DRYALYSATE CONCENTRATE

K980659 · Advanced Renal Technologies, Inc. · KPO · Jun 11, 1998 · Gastroenterology, Urology

Device Facts

• Record ID: K980659
• Device Name: DRYALYSATE CONCENTRATE
• Applicant: Advanced Renal Technologies, Inc.
• Product Code: KPO · Gastroenterology, Urology
• Decision Date: Jun 11, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5820
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

DRYalysate™ Concentrate is intended for use for patients being treated by hemodialysis. The primary patient population that will use this device are those who suffer from loss of kidney function and who are prescribed acute or chronic hemodialysis. The indications for use of this product are exactly the same as those for currently marketed dialysate concentrates.

Device Story

DRYalysate™ Concentrate consists of packaged dry chemicals; mixed with AAMI quality water to create acid concentrate for hemodialysis. Available in single-dose (5L) or bulk (50L) packages. Used in proportioning hemodialysis machines; functions identically to existing liquid concentrates. Citric acid serves as the acidifying agent. Intended for clinical use in patients with kidney failure; prescribed by physicians. Benefits include convenience of dry storage and transport compared to liquid concentrates.

Clinical Evidence

Three clinical studies were submitted to support safety and effectiveness. No specific performance metrics (e.g., p-values, CIs) were provided in the summary document.

Technological Characteristics

Dry chemical powder for reconstitution with AAMI quality water. Acidifying agent: citric acid. Form factor: single-dose or bulk packaging. Used in standard proportioning hemodialysis machines.

Indications for Use

Indicated for patients with loss of kidney function requiring acute or chronic hemodialysis.

Regulatory Classification

Identification

A hemodialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in the blood compartment, undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer.(1) The extracorporeal blood system and accessories consists of tubing, pumps, pressure monitors, air foam or bubble detectors, and alarms to keep blood moving safely from the blood access device and accessories for hemodialysis (§ 876.5540) to the blood compartment of the dialyzer and back to the patient. (2) The conventional dialyzer allows a transfer of water and solutes between the blood and the dialysate through the semipermeable membrane. The semipermeable membrane of the conventional dialyzer has a sufficiently low permeability to water that an ultrafiltration controller is not required to prevent excessive loss of water from the patient's blood. This conventional dialyzer does not include hemodialyzers with the disposable inserts (Kiil type) (§ 876.5830) or dialyzers of high permeability (§ 876.5860). (3) The dialysate delivery system consists of mechanisms that monitor and control the temperature, conductivity, flow rate, and pressure of the dialysate and circulates dialysate through the dialysate compartment of the dialyzer. The dialysate delivery system includes the dialysate concentrate for hemodialysis (liquid or powder) and alarms to indicate abnormal dialysate conditions. This dialysate delivery system does not include the sorbent regenerated dialysate delivery system for hemodialysis (§ 876.5600), the dialysate delivery system of the peritoneal dialysis system and accessories (§ 876.5630), or the controlled dialysate delivery system of the high permeability hemodialysis system § 876.5860). (4) Remote accessories to the hemodialysis system include the unpowered dialysis chair without a scale, the powered dialysis chair without a scale, the dialyzer holder set, dialysis tie gun and ties, and hemodialysis start/stop tray.

Predicate Devices

• Granuflo™ Dry Acid Concentrate (K911459, K922005)
• Dial Medical of Florida, Inc. Hemodialysis Concentrates (K864265)
• Granite Chemical GC-1000, GC-2000 and GC-3000 formulas (K901471)

Submission Summary (Full Text)

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Page 1 of 3

K980659

# 510 (k) SUMMARY

The information contained on the following pages is required to be included pursuant to \$807.87 (h) of 21 CFR which cross-references to the requirements of \$807.92. The information follows the order asked for in §807.92:

## SUBMITTER

Submitter:

Advanced Renal Technologies

Address:

2151 N. Northlake Way, Suite #200 Seattle, WA 98103

Phone:

Robin Callan

[phone]

Date prepared:

Contact person:

" " January 9, 1998

#### DEVICE NAME

Proprietary Name:

DRYalysate™ Concentrate.

Common/Usual Name:

- Acid Concentrate, 'A' component of bicarbonate dialysate, "A Concentrate" and granulated or powdered dialysate concentrate for hemodialysis.
Classification Name:

Dialysate Concentrate for Hemodialysis.

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## PREDICATE DEVICES

1980659

DRYalysate™ Concentrate is a powdered concentrate substantially equivalent to the powdered dialysate products supplied by Fresenius USA sold as Granuflo™ Dry Acid Concentrate (originally granted FDA marketing approval as Granulyte™ Powder Dialysate Concentrate; 510 (k) #'s K911459 and K922005), Dial Medical's DMF (Dial Medical of Florida, Inc.) Hemodialysis Concentrates; 510 (k) # K864265, and Granite Chemical's GC-1000, GC-2000 and GC-3000 formulas; 510 (k) # K901471, all of which have been determined equivalent to pre-enactment devices.

Available dialysate concentration formulations supplied by these predicate device manufacturers were provided.

### DEVICE DESCRIPTION

The device consists of packaged dry chemicals which, when mixed and dissolved with AAMI quality water, according to the directions for use, makes an acid concentrate that can be used by current proportioning type hemodialysis machines to make dialysate.

DRYalysate™ Concentrate will be packaged and sold in two convenient boxed sizes; a 'single dose' package designed to make enough dialysate concentrate (5 Liters) for one patient for one treatment and a 'bulk' package which contains enough powder to make 50 liters of dialysate at a time.

Once the package of chemicals is mixed according to the instructions for use, the resulting liquid concentrate is used in the hemodialysis process in proportioning type hemodialysis machines in exactly the same way that existing concentrates are used.

A list of available DRYalysate™ final dialysate formulations was provided.

#### STATEMENT OF INTENDED USE

DRYalysate™ Concentrate is intended for use for patients being treated by hemodialysis. The primary patient population that will use this device are those who suffer from loss of kidney function and who are prescribed acute or chronic hemodialysis. The indications for use of this product are exactly the same as those for currently marketed dialysate concentrates.

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## STATEMENT OF EQUIVALENCE

1296 501 3

1980659

The intended use of DRY alysate™ Concentrate is identical with that of currently marketed dialysate concentrates.

A comparison of the technological characteristics (chemical formulation) of DRYalysate™ Concentrate with currently marketed dialysate concentrates demonstrates that the only substantive change is the use of citric acid as the acidifying agent, otherwise the formulations are identical.

The concentration ranges of ART DRYalysate™ Concentrates were provided.

### ASSESSMENT OF PERFORMANCE DATA

The three clinical studies and other testing data submitted provide the necessary and sufficient evidence to support that Advanced Renal Technologies DRYalysate™ Concentrate is cafe and effective and substantially equivalent to currently marketed products.

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Image /page/3/Picture/16 description: The image shows a circular seal or logo. The text around the top of the circle reads "U.S.A.", and the text around the bottom of the circle reads "DEPARTMENT OF HEALTH & HUM.". Inside the circle is a stylized graphic of three human profiles facing right, with flowing lines beneath them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 1998

Ms. Robin Callan President Advanced Renal Technologies 2151 N. Northlake Way, Suite 200 Seattle, WA 98103

Re: K980659 ART DRYalysate™ Concentrate Dated: May 14, 1998 Received: May 15, 1998 Regulatory Class: II 21 CFR \$876.5820/Procode: 78 KPO

Dear Ms. Callan:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations,

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address "http://www.fda.gov/cdrb/dsmaldsmamain.html".

Sincerely yours

Lillian Yin, Ph.D.

Director, Division of Reproductive, Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### 510 (k) Number

None asigned at this time.

#### Device Name

DRYalysate™ Concentrate

#### Indications for Use

DRYalysate™ Concentrate is indicated for use for patients being treated by hemodialysis. The patient population that will use this device are those who suffer from loss of kidney function and who are prescribed acute or chronic hemodialysis. The indications for use of this product are exactly the same as those for currently marketed dialysate concentrates.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Robert Sattley/

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number .

Prescription Use (per 21 CFR 801.109)

Over-the-Counter Use

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